Enforcement Report - Week of January 16, 2013
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Product Detail
| Product Description | UltraFill DBM labeled in part: ***TISSUENET***Sterilized by T10^6 (r)***Description: UltraFill DBM***Size: 5cc***Product Code: RT53005***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***FOR INTERNATIONAL USE ONLY***See Package Insert for Additional Information*** TissueNet's Porcine DBM product line is used as a bone void filler. |
|---|---|
| Recall Number | Z-0652-2013 |
| Classification | Class II |
| Code Info | Product Code: RT53005 Tissue ID: TN48005-11-0021 through TN48055-11-0059; TN48055-11-0070 through TN48055-11-0075; TN58063-11-0101 through TN58063-11-0142; TN61039-11-0031 through TN61039-11-0097; TN70037-11-0017 through TN70037-11-0018; TN70037-11-0020 through TN70037-11-0037; TN74060-11-0021 through TN74060-11-0047; TN74060-11-0050 through TN74060-11-0056 |
| Product Distributed Qty | 208 units |
| Reason For Recall | Surgical Tissue Network Inc., DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc; 5cc; 10cc) because products may contain trace amounts of 316L Stainless Steel particulates. |
Event Detail
| Event Id | 63226 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Surgical Tissue Network, Inc. |
| City | Orlando |
| State | FL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-03-14 |
| Initial Firm Notification of Consignee or Public | |
| Distribution Pattern | Worldwide Distribution including Turkey, Greece, & Mexico. |
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